Hydrophilicity alteration system and method

ABSTRACT

A system/method allowing hydrophilicity alteration of a polymeric material (PM) is disclosed. The PM hydrophilicity alteration changes the PM characteristics by decreasing the PM refractive index, increasing the PM electrical conductivity, and increasing the PM weight. The system/method incorporates a laser radiation source that generates tightly focused laser pulses within a three-dimensional portion of the PM to affect these changes in PM properties. The system/method may be applied to the formation of customized intraocular lenses comprising material (PLM) wherein the lens created using the system/method is surgically positioned within the eye of the patient. The implanted lens refractive index may then be optionally altered in situ with laser pulses to change the optical properties of the implanted lens and thus achieve optimal corrected patient vision. This system/method permits numerous in situ modifications of an implanted lens as the patient&#39;s vision changes with age.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of co-pending U.S. patent applicationfor HYDROPHILICITY ALTERATION SYSTEM AND METHOD by inventors Ruth (nmn)Sahler, Stephen Q. Zhou, and Josef F. Bille, filed electronically withthe USPTO on Mar. 15, 2013, with Ser. No. 13/843,464, which claimsbenefit under 35 U.S.C. §119 and incorporates by reference United StatesProvisional patent application for HYDROPHILICITY ALTERATION SYSTEM ANDMETHOD by inventors Ruth (nmn) Sahler, Stephen Q. Zhou, and Josef F.Bille, filed electronically with the USPTO on Nov. 14, 2012, with Ser.No. 61/726,383, EFS ID 14230078, confirmation number 5116, docketAAARE.0107P.

PARTIAL WAIVER OF COPYRIGHT

All of the material in this patent application is subject to copyrightprotection under the copyright laws of the United States and of othercountries. As of the first effective filing date of the presentapplication, this material is protected as unpublished material.

However, permission to copy this material is hereby granted to theextent that the copyright owner has no objection to the facsimilereproduction by anyone of the patent documentation or patent disclosure,as it appears in the United States Patent and Trademark Office patentfile or records, but otherwise reserves all copyright rights whatsoever.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

REFERENCE TO A MICROFICHE APPENDIX

Not Applicable

FIELD OF THE INVENTION

The present invention relates to the modification of the hydrophilicityof a material. The hydrophilicity of the material is changed by exposingthe material to targeted laser pulses. The laser pulses are absorbed andalter chemical bonds of the molecules within the material. The material(if hydrophobic) then either absorbs water because of the alteredmolecular structure or rejects water (if the material is hydrophilic).By way of example only, the present invention teaches a laser system anda method for modifying the hydrophilicity of an optical lens in apredetermined region inside the lens bulk body with or without ahydrophilicity change on the lens surfaces. The material used in theexperiments described herein as applied to the present invention is apolymeric acrylic lens material (PLM) but this material selection isexemplary and should not be treated as a limitation of the presentinvention.

PRIOR ART AND BACKGROUND OF THE INVENTION Background (0100)-(0400)

Conventionally, intraocular lenses are manufactured using cutting ormolding techniques to fabricate polymer-based lenses which may need atumbling step to acquire optical grade quality. Optical lenses can besurface modified by physical and chemical methods.

Physical methods include, but are not limited to plasma, coronadischarge, and microwave processes. This treatment can change thehydrophilicity of the lens surface. For example, U.S. Pat. No. 5,260,093issued on Nov. 9, 1993 to Ihab Kamel and David B. Soll for METHOD OFMAKING BIOCOMPATIBLE, SURFACE MODIFIED MATERIALS disclosed a method forpermanently modifying the surface of a substrate material by radiofrequency plasma. One of the substrates in disclosed in this patent isan intraocular lens.

Chemical modification of optical lenses is also well known. The chemicalmodification of optical lenses can change the chemical composition onthe surface, thus this not only changes the hydrophilicity of the lenssurface, but also the physical and chemical properties of the surface aswell. For example, U.S. Pat. No. 6,011,082 issued on Jan. 4, 2000 toYading Wang, Robert van Boxtel, and Stephen Q. Zhou for PROCESS FOR THEMODIFICATION OF ELASTOMERS WITH SURFACE INTERPRETING POLYMER NETWORKSAND ELASTOMERS FORMED THEREFROM disclosed a chemical modification methodwhich allows a polymeric silicone intraocular lens to be chemicallymodified into a hydrophilic surface by heparin as well as otherhydrophilic agents.

However, the above prior art methods can only be used to treat the lenssurfaces. They cannot be used to modify the hydrophilicity of the lensbulk body below the surface. In other words, they cannot be used totreat a predetermined region inside a lens material.

In contrast, recent laser technology has made it possible to selectivelytarget a predetermined region inside a material, including optical lensmaterials without changing the lens surface. For example, United StatesPatent Application Publication US2002/0117624A for PLASTIC OBJECTpublished on Aug. 29, 2002 having inventors Shigeru Katayama and MikaHoriike disclosed a general method using a laser to fabricate a plasticobject which has been structurally modified in one part of its internalbody by a laser light of ultrashort pulse duration of 10⁻¹² second orshorter. Examples of internal structures created using this prior arttechnique are generally illustrated in FIG. 1 (0100) and FIG. 2 (0200).

A more recent application in United States Patent ApplicationPublication US2008/0001320A1 for OPTICAL MATERIAL AND METHOD FORMODIFYING THE REFRACTIVE INDEX published on Jan. 3, 2008 havinginventors Wayne H. Knox, Li Ding, Jay Friedrich Kunzler, and DharmendraM. Jani disclosed a method for modifying the refractive index of anoptical polymeric material comprising irradiating the selected region byfemtosecond laser pulses (using a system configuration as generallyillustrated in FIG. 3 (0300)) resulting in the formation of refractiveoptical structure of the laser treated region which is characterized bya positive change in refractive index. This patent applicationpublication also disclosed calculating the refractive index change (Ln)as positive in the range of 0.03 to 0.06. This prior art teaches that ifthe selected treatment region is a convex-plano shape, it will create apositive lens while if the treated region is a biconcave shape, then itwill be a negative lens. This is described in drawings of theUS2008/0001320A1 patent application publication and is reproduced asFIG. 4 (0400) herein.

The prior art does not address the modification of the hydrophilicity ofan internal region of a material.

Deficiencies in the Prior Art

While the prior art as detailed above can theoretically be used to formoptical lenses, it suffers from the following deficiencies:

-   -   Prior art limits the lens formed within the lens material to        2.65 diopter in change for a lens with a 200 micron thickness        and 6 mm diameter while the present invention creates a up to a        20 diopter lens with the same lens diameter.    -   Prior art requires several hours to create a 2.65 diopter lens        while the present invention would produce the same lens in a few        minutes. Prior art paper publication show a shaping speed of 0.4        um/s for the high refractive index change. The following        parameters have been used: a spot size of 1 um in XY and 2.5 um        in Z and a convex lens diameter with 6 mm and a lens depth of        200 um. Source: Li Ding, Richard Blackwell, Jay F. Künzler and        Wayne H. Knox “LARGE REFRACTIVE INDEX CHANGE IN SILICONE-BASED        AND NON-SILICONE-BASED HYDROGEL POLYMERS INDUCED BY FEMTOSECOND        LASER MICRO-MACHINING”.    -   Prior art can only produce a positive diopter change assuming a        convex lens while the instant invention can only produce a        negative diopter change using a convex lens.    -   Prior art is limited to one lens within the material while the        invention can stack multiple lens to increase the diopter change        or alter asphericity, toricity or other lens properties.    -   Prior art discloses no relationship between hydrophilicity        change and UV absorption while the instant invention relies on        UV absorption to effect the change in hydrophilicity.    -   Prior art makes no change in hydrophilicity and the instant        invention relies upon a change in hydrophilicity to effect the        change in the material.        To date the prior art has not fully addressed these        deficiencies.

OBJECTIVES OF THE INVENTION

Accordingly, the objectives of the present invention are (among others)to circumvent the deficiencies in the prior art and affect the followingobjectives:

-   -   (1) provide for a system and method that permits the        modification of the hydrophilicity of the interior of a material        with or without a change in the hydrophilicity of the surface of        the material;    -   (2) provide for a system and method that alters the        hydrophilicity of an entire predetermined three dimensional        region within a polymeric material;    -   (3) provide a system and method of manufacturing an optical        lens; and    -   (4) provide a system and method for altering the hydrophilicity        of a predetermined internal region of an implanted intraocular        lens thus altering the refractive properties of the implanted        intraocular lens according to the individual patient's need for        a desirable vision outcome.

While these objectives should not be understood to limit the teachingsof the present invention, in general these objectives are achieved inpart or in whole by the disclosed invention that is discussed in thefollowing sections. One skilled in the art will no doubt be able toselect aspects of the present invention as disclosed to affect anycombination of the objectives described above.

BRIEF SUMMARY OF THE INVENTION

The present invention pertains to a system, method, andproduct-by-process wherein a pulsed laser system is used to modify thehydrophilicity of a polymeric material (the material used in allreferenced experiments was a polymeric acrylic polymer (“PLM”) howeverthat material is used as an example and is not limitation of the presentinvention scope). The change in hydrophilicity may be used to:

-   -   form an optical lens having predetermined refractive properties;    -   create hydrophilic areas in an otherwise hydrophobic material;        or    -   create hydrophilic areas in an otherwise hydrophilic material.

The present invention is particularly, but not exclusively, useful asdescribing the procedure to create a very thin, multi-layered,micro-structured customized intraocular lens inside a PLM. Thistechnique could be used, but is not limited to modifications of anexisting lens which is currently implanted within a human eye. Themodifications can adjust diopter and/or add additional properties liketoricity and asphericity. The instant invention is capable of creatingnew lenses which are thinner than existing products and can be injectedthrough a small incision. In particular, a system and method for theshaping of a refractive index within lenses based on the modification ofthe hydrophilicity of the material is disclosed.

The present invention describes a laser system and a method formodifying the hydrophilicity for a predetermined internal region of PLMwhich may be used as an optical lens. The present invention can beutilized to modify the optical properties of an optical lens by adding(or reducing) its optical power, or altering its asphericity,multifocalilty, toricity and other optical properties. Typicalapplication for this invention may include correcting thepost-operational residual refractive error of an intraocular lens whichhas already been implanted in a patient's eye.

In spite of the best effort by surgeons, residual refractive error isinevitable in many cases due to deviations in lens power selection,patient's history of past eye surgeries such as LASIK procedure, surgeryinduced astigmatism, and progressive change in vision of a patient.Currently, surgeons use LASIK, a procedure to reshape a patient's corneaby destroying a portion of the cornea by laser beams, to correctresidual refractive error after cataract surgery. Alternatively,patients may need to wear eye glasses to correct post-operationalrefractive errors. The present invention promotes a scenario in whichthese optical non-idealities may be corrected in situ after the cataractsurgery is completed.

Within the scope of the present invention a customized intraocular lensmay be manufactured using either all optical processes or a combinationof the traditional manufacturing in combination with optical processesto reduce the lens thickness and the needed incision size. The opticalprocess is typically employed by using a femtosecond laser with pulseenergies of 0.17 to 500 nanjoules and a megahertz repetition rate of 1to 100.

The focus spot of the laser beam is moved inside the lens material tocreate a pattern of changes in the material, creating a threedimensional lens. Different patterns will provide different lensproperties, for example a toric or aspheric lenses.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the advantages provided by the invention,reference should be made to the following detailed description togetherwith the accompanying drawings wherein:

FIG. 1 illustrates a prior art methodology of internal plasticmodification as taught by United States Patent Application PublicationUS2002/0117624A;

FIG. 2 illustrates a prior art methodology of internal plasticmodification as taught by United States Patent Application PublicationUS2002/0117624A;

FIG. 3 illustrates a prior art system for lens formation as taught byUnited States Patent Application Publication US2008/0001320A1;

FIG. 4 illustrates a prior art lens form as taught by United StatesPatent Application Publication US2008/0001320A1;

FIG. 5 illustrates an exemplary system block diagram depicting apreferred exemplary system embodiment of the present invention;

FIG. 6 illustrates an exemplary system block diagram of a preferredexemplary system embodiment of the present invention depicting a typicalinvention application setup context;

FIG. 7 illustrates a detail system block diagram illustrating systemcomponents that may be used to implement some preferred inventionembodiments;

FIG. 8 illustrates a comparison of prior art lens configurations using aconvex lens for optical convergence and present invention a lensconfigurations using a concave lens for optical convergence;

FIG. 9 illustrates the use of the present invention to modify thehydrophilicity of a PLM in single and multiple layer configurations;

FIG. 10 illustrates an exemplary convex/biconvex lens structure astaught by the present invention;

FIG. 11 illustrates an exemplary concave/biconcave lens structure astaught by the present invention;

FIG. 12 illustrates exemplary phase wrapping lens structures that may beformed using the teachings of the present invention;

FIG. 13 illustrates the refractive index patterns associated withexemplary phase wrapping lens structures that may be formed using theteachings of the present invention;

FIG. 14 illustrates an exemplary PLM hydrophilicity alteration methodflowchart used in some preferred embodiments of the present invention;

FIG. 15 illustrates an exemplary lens shaping/formation method flowchartused in some preferred embodiments of the present invention;

FIG. 16 illustrates an exemplary lens calculation method flowchart usedin some preferred embodiments of the present invention;

FIG. 17 illustrates an exemplary experimental sample PLM structure astaught by the present invention;

FIG. 18 illustrates a graph of experimentally measured PLM waterabsorption measurements;

FIG. 19 illustrates an exemplary diffraction grid pattern as taught bythe present invention;

FIG. 20 illustrates an exemplary experimental refractive indexmeasurement setup as taught by the present invention;

FIG. 21 illustrates an exemplary experimental refractive index patternas taught by the present invention;

FIG. 22 illustrates an exemplary experimentally measured diffractiongrating power measurement over time as taught by the present invention;

FIG. 23 illustrates an exemplary experimentally measured diffractiongrating 0 order power measurement as taught by the present invention;

FIG. 24 illustrates an exemplary experimentally measured waterde-absorption curve as taught by the present invention;

FIG. 25 illustrates an exemplary experimentally constructed convex phasewrapping DIC and theoretical side view as taught by the presentinvention;

FIG. 26 illustrates a NIMO diopter reading of an exemplaryexperimentally constructed convex phase wrapping DIC and theoreticalside view as taught by the present invention;

FIG. 27 illustrates an exemplary experimentally constructed concavephase wrapping DIC and theoretical side view as taught by the presentinvention;

FIG. 28 illustrates a NIMO diopter reading of an exemplaryexperimentally constructed concave phase wrapping DIC and theoreticalside view as taught by the present invention;

FIG. 29 illustrates an exemplary experimental 3 mm convex phase wrappinglens top view as constructed;

FIG. 30 illustrates an exemplary experimentally measured diopter readingas it relates to water absorption comparison as taught by the presentinvention, depicting the difference between air drying and waterhydration on measured lens diopter readings;

FIG. 31 illustrates an exemplary experimentally measured waterabsorption curve for water as taught by the present invention and itsvariation based on time and ambient temperature;

FIG. 32 illustrates an exemplary experimentally measured waterabsorption diopter dependency graph as taught by the present invention;

FIG. 33 illustrates an exemplary method flowchart depicting ageneralized in-vivo lens shaping method as implemented by a preferredinvention embodiment;

FIG. 34 illustrates an exemplary method flowchart depicting preparationdetails of an in-vivo lens shaping method as implemented by a preferredinvention embodiment;

FIG. 35 illustrates an exemplary method flowchart depicting lens datacreation details of an in-vivo lens shaping method as implemented by apreferred invention embodiment;

FIG. 36 illustrates an exemplary method flowchart depicting patientinterface details of an in-vivo lens shaping method as implemented by apreferred invention embodiment;

FIG. 37 illustrates an exemplary method flowchart depicting startinitialization details of an in-vivo lens shaping method as implementedby a preferred invention embodiment;

FIG. 38 illustrates an exemplary method flowchart depicting diagnosticsdetails of an in-vivo lens shaping method as implemented by a preferredinvention embodiment;

FIG. 39 illustrates an exemplary method flowchart depicting lens shapingdetails of an in-vivo lens shaping method as implemented by a preferredinvention embodiment;

FIG. 40 illustrates an exemplary method flowchart depicting verificationdetails of an in-vivo lens shaping method as implemented by a preferredinvention embodiment;

FIG. 41 illustrates an exemplary method flowchart depicting ageneralized manufacturing custom lens shaping method as implemented by apreferred invention embodiment;

FIG. 42 illustrates an exemplary method flowchart depicting preparationdetails of a manufacturing custom lens shaping method as implemented bya preferred invention embodiment;

FIG. 43 illustrates an exemplary method flowchart depicting lens datacreation details of a manufacturing custom lens shaping method asimplemented by a preferred invention embodiment;

FIG. 44 illustrates an exemplary method flowchart depicting positioningdetails of a manufacturing custom lens shaping method as implemented bya preferred invention embodiment;

FIG. 45 illustrates an exemplary method flowchart depicting startinitialization details of a manufacturing custom lens shaping method asimplemented by a preferred invention embodiment;

FIG. 46 illustrates an exemplary method flowchart depicting diagnosticsdetails of a manufacturing custom lens shaping method as implemented bya preferred invention embodiment;

FIG. 47 illustrates an exemplary method flowchart depicting lens shapingdetails of a manufacturing custom lens shaping method as implemented bya preferred invention embodiment;

FIG. 48 illustrates an exemplary method flowchart depictingverification/shipping details of a manufacturing custom lens shapingmethod as implemented by a preferred invention embodiment.

DESCRIPTION OF THE PRESENTLY PREFERRED EXEMPLARY EMBODIMENTS

While this invention is susceptible of embodiment in many differentforms, there is shown in the drawings and will herein be described indetailed preferred embodiment of the invention with the understandingthat the present disclosure is to be considered as an exemplification ofthe principles of the invention and is not intended to limit the broadaspect of the invention to the embodiment illustrated.

The numerous innovative teachings of the present application will bedescribed with particular reference to the presently preferredembodiment, wherein these innovative teachings are advantageouslyapplied to the particular problems of a HYDROPHILICITY ALTERATION SYSTEMAND METHOD. However, it should be understood that this embodiment isonly one example of the many advantageous uses of the innovativeteachings herein. In general, statements made in the specification ofthe present application do not necessarily limit any of the variousclaimed inventions. Moreover, some statements may apply to someinventive features but not to others.

Hydrophilicity Not Limitive

Within the context of the present invention the term “hydrophilicity”will be defined as the characteristic of a material to “have a strongaffinity for water or tend to dissolve in, mix with, or be wetted bywater.”

Material (PLM) Not Limitive

The present invention may incorporate a wide range of materials,including the PLM but not limited to the PLM, within the scope ofanticipated embodiments, many of which may be application specific. PLMmay in many preferred embodiments incorporate the use of an ultraviolet(UV) (generally 300-400 nm wavelength) absorbing material to augment theabsorption of pulsed laser energy by the PLM and thus affect a change inhydrophilicity of the PLM. PLM as used herein should not be constrainedas limiting its use to materials that form optical lenses. Specifically,the term “polymeric material (PM)” may be used herein to denoteapplications of the invention system/method/product that are notnecessarily limited to the production of optical lenses. Thus, “PM” maycover a broader application of the invention concepts than “PLM”,although the materials may be identical. Therefore, the term “polymericlens material (PLM)”, “polymeric material (PM)” and their equivalentsshould be given the broadest possible meaning within this context.

UV Absorbers Not Limitive

The PLM may incorporate a number of chemicals which may enhance the UVabsorption of the PLM and thus enhance the change in the PLM'shydrophilicity when irradiated with pulsed laser radiation. The presentinvention makes no limitation on the types and quantities of chemicalsused to affect this behavior, and the recitation of these chemicalswithin this document is only exemplary of those anticipated.

Laser Radiation not Limitive

The present invention may incorporate a wide variety of laser radiationto affect changes in hydrophilicity within the PLM described herein toform a lens. Therefore, the term “laser radiation” and its equivalentsshould be given the broadest possible meaning within this context, andnot limited to near infrared light laser radiation.

Laser Source not Limitive

The present invention may incorporate a wide variety of laser radiationsources provide the required pulsed laser radiation used within thedisclosed invention. Within this context, the term “laser source” mayalso incorporate an Acousto-Optic Modulator (AOM) (also called a Braggcell) that uses the acousto-optic effect to diffract and shift thefrequency of laser light generated using sound waves (usually atradio-frequency). Within this context, the “laser source” may beglobally defined as comprising a laser radiation source and optionallyan AOM, whether or not the AOM is physically incorporated into the laserradiation source hardware. Therefore, the term “laser source” and itsequivalents should be given the broadest possible meaning within thiscontext.

Acousto-Optic Modulator (AOM) not Limitive

Various invention embodiments may make use of an Acousto-Optic Modulator(AOM) to act as a switch to enable/disable or moderate the quantity oflaser radiation pulse stream as directed to the laser scanner within thecontext of the invention. Within this context the AOM may incorporate“greyscale” modulation wherein the switching function serves to switch aportion of the laser radiation pulse train to the laser scanner andtherefore permit reductions in effective laser power as applied to thetargeted PLM to which the hydrophilicity is to be modified. Thus, theutilization of “greyscale AOM” components to modulate laser radiationintensity is specifically anticipated within the scope of the invention.

The AOM as depicted in the present invention is used as a shutter and asvariable attenuator and as such could therefore be replaced with anotherequivalent component which simulates the same functionality as describedabove.

Laser Scanner not Limitive

The use of a laser scanner within the preferred invention embodimentsdescribed herein may incorporate many different varieties of scanner,including but not limited to flying spot scanners (generallyvector-based modes) and raster scanners (generally raster-based modes).The scanner is used to distribute the laser pulse to the correctlocation within the objectives field size. The present invention makesno limitation on the type of laser scanner that may be used in thiscontext.

Microscope Objective not Limitive

References herein to a “microscope objective” may equivalently utilize a“microscope objective or other focusing device” to achieve thesefunctions. Thus, the term “microscope objective” should be given itsbroadest possible interpretation within this application context.

Patient not Limitive

The present invention may be applied to situations where a lens placedin a living creature is modified in situ to correct/modify therefractive properties of the lens without removal from the eye of thecreature. Within this context, the term “patient” shall be broadlyconstrued and should not be limited to application only on human beings.

Lens Form not Limitive

The present invention may incorporate a wide variety of lenses formed toaffect optical light bending and thus the construction of an overalllens formation. While exemplary embodiments of the present invention aredescribed herein as being used to construct convex, biconvex, concave,biconcave, and plano lens structures, these structures are onlyexemplary of a plethora of lens forms that may be constructed with thepresent invention. Therefore, the term “lens formation” and itsequivalents should be given the broadest possible meaning within thiscontext.

Two-Dimensional not Limitive

The present invention may incorporate the use of two-dimensional patternstructures within the PLM to form diffraction gratings and other thinplanar structures which while technically three-dimensional, will betermed herein as two-dimensional. While no modification of the PLMhydrophilicity can occur strictly in a zero-thickness plane, the termtwo-dimensional will refer to the creation of structures which occurwithin the PLM that do not require Z-axis focus repositioning across theX-Y plane perpendicular to the optical axis. Thus, a two-dimensionalmodification of the PLM refractive index could occur along a non-planarboundary that comprises a singular Z-axis focal distance for the laserpulses. Therefore, the term “two-dimensional” and its equivalents shouldbe given the broadest possible meaning within this context.

Three-Dimensional not Limitive

The present invention may incorporate the use of three-dimensionalpattern structures within the PLM to form complex optical structures.These three-dimensional pattern structures and their associated volumesmay comprise multiple layers having interstitial PLM having ahydrophilicity that has not been modified by irradiation with laserpulses. Thus, a three-dimensional structure may incorporate non-modifiedareas having unmodified or slightly modified layer, or multiple layerscomprising differing levels of hydrophilicity and resulting refractiveindex changes. Therefore, the term “three-dimensional” and itsequivalents should be given the broadest possible meaning within thiscontext.

Intraocular Lens not Limitive

The present invention may be advantageously applied to the constructionof dynamically adjustable optical lenses incorporating a wide range ofmaterials. The mechanisms of incorporation of a wide variety ofmaterials within the optical lens are not limited by the presentinvention. Therefore, the term “intraocular lens” and “optical lens(which would include contact lenses)” and its equivalent constructionembodiments should be given the broadest possible meaning within thiscontext.

General System Description

The present invention may be generally described as utilizing a lasersystem which consists of a femtosecond laser source, an AOM, a scanner,and an objective which delivers the laser pulses into the predeterminedregion. The laser source preferably has a pulse duration ofapproximately 350 fs or shorter, a wavelength in the range of 690 to1000 nm, and a repetition rate of between approximately 0.1 to 100 MHz.The pulse energy is typically in the range of 0.17 to 500 nanojoules.Those who are skilled in the art understand that these laser parameterscan be adjusted and rebalanced to be outside above-specified range butstill be able to achieve the same level of energy delivered to thetargeted regions of the lens material. For example, a tunable laserunit, such as Ti:Saphphire oscillator (Mai Tai By Newport, Irvine,Calif.) can provide a variable wavelength in the range of approximately690-1040 nm, a pulse width of as low as 70 fs, and a source power up to2.9 W.

Generalized Hydrophilicity Modification System (0500)

A preferred exemplary system embodiment of the present invention isgenerally illustrated in FIG. 5 (0500), wherein a material (0501) isirradiated (0515) to produce a change in hydrophilicity within aselected region (0502) within the PLM (0501). This system (0500)generally incorporates a laser source (0511) that is configured togenerate pulsed laser radiation which may becontrolled/moderated/modulated/switched by an acousto-optic modulator(AOM) (0512) to produce a predetermined laser pulse train havingspecified energy and pulse timing characteristics. In some inventionembodiments the laser source (0511) and AOM (0512) may be integratedinto a single laser source module. The pulsed laser radiation generatedby the laser source (0511)/AOM (0512) is then transmitted to a laserscanner (0513) that is configured to distribute the laser pulses in anX-Y plane across an input area of a microscope objective (0514). Themicroscope objective (0514) incorporates a numerical aperture configuredto accept the distributed pulsed laser radiation and produce a focusedlaser radiation output (0515). This focuses laser radiation output(0515) is then transmitted by the microscope objective (0514) to apolymeric lens material (PLM) (0501) region (0502) in which thehydrophilicity of the PLM (0501) is to be changed. The position of thehydrophilic-modified PLM region (0502) may be defined by the laserscanner (0513) as well as a sample staging/positioning system (0516)that mechanically positions the PLM (0501) to allow the focused laserpulses (0515) to be properly localized within the desired interiorregion (0502) of the PLM (0501).

This system may optimally operate under control of a computer controlsystem (0520) incorporating a computer (0521) executing software readfrom a computer readable medium (0522) and providing a graphical userinterface (GUI) (0523) from which an operator (0524) may direct theoverall operation of the hydrophilicity change (0502) within the PLM(0501).

System/Method Application Context Overview (0600)

A typical application context for the present invention is generallyillustrated in FIG. 6 (0600), wherein the present invention is embodiedin a hydrophilicity alteration system (0610) used to configure patientlenses. This hydrophilicity alteration system (0610) typically comprisesa laser source (0611) that generates a pulsed laser output that is thendistributed in an X-Y plane using a laser scanner (0613) and thenfocused using a microscope objective (0614) (or other focusingapparatus). This distributed and focused pulsed laser radiation (0615)is transmitted within a lens structure (0601) having some portion ofwhich that is constructed of material (PLM) (0602). This PLM (0602) isirradiated in a two or three-dimensional pattern (0603) within the PLMstructure (0602) to modify the hydrophilicity. Any modifications inhydrophilicity will create some change in the refractive index of theinternal region of the PLM (0603). This change in refractive indexgenerated by the focused laser pulses (0614) causes the two orthree-dimensional pattern (0603) to form an optical lens function withinthe overall lens structure (0601).

In conjunction with this general system/method configuration, the lensstructure (0601) may be incorporated (0604) within a human eye (0605)and the PLM (0602) modified in situ after the lens structure (0601) hasbeen surgically implanted within the eye of a patient as generallyillustrated in the diagram.

The described hydrophilicity alteration system (0610) is typicallyoperated under control of a computer system (0621) executinginstructions from a computer readable medium (0622). This computerizedcontrol (0621) optimally incorporates a graphical user interface (0623)permitting the system operator (0624) to interface with the overallsystem and direct its operation. With respect to the above-mentioned insitu lens formation application, the control software (0622) mayincorporate software implementing methods to perform an automatedpatient eye examination to determine the non-idealities in the patient'svision (0625), from which a map of optical corrections (0626) necessaryto improve the patient's vision is generated, followed by automatedlaser pulse/position control procedures to change in situ the refractiveindex of PLM within the patient lens to fully correct the patient vision(0627).

System/Method Application Context Detail (0700)

A more detailed system configuration of a preferred inventionapplication context is provided in FIG. 7 (0700), wherein a computersystem (0720) operating under control of software read from a computerreadable media (0721, 0722) is used to control and supervise the overalllens fabrication process. Within this application context, the followingcomponents generally comprise the system:

-   -   The laser source (0701) with a wavelength suitable to treat the        desired material and an energy-per-pulse sufficient to change        the refractive index of the target area provided by the used        objective (0710).    -   The Dispersion Compensator (0702) is used to pre-compensation        the beam to allow a pulse width around 100 fs. Without the        feature the pulse width at the target would be larger because        the pulse width gets longer when passing through an optical        media like a lens. With a longer pulse with more heat would        occur on the treatment area, making the process a little more        imprecise and the treatment time a little longer. This feature        therefore is optional but part of the RIS optimization.    -   The Beam Shaping 1 (0703) unit can be used to modify the laser        beam diameter to fit the AOM specifications. This also allows        the exchange of the laser source without additional        modifications after the beam shaping 1 unit.    -   The AOM (0704) is used to modulate the number of pulses and the        energy per pulse which will be directed to the treatment area.        Depending on the received signal (normally 0 to 5V) the energy        will be distributed to the 0 or the 1^(st) order of the AOM.        Those orders are two different beams, with an angle between        them, coming out from the AOM. The 1^(st) order beam is normally        the one going to the target area and the 0 order beam is stopped        directly after the AOM. The receiving signal from the AOM driver        is maximum (eg 5V) the maximum energy per pulse is in the 1^(st)        order beam, when the driver signal is at the minimum the 1^(st)        order beam will have 0% energy and everything will be delivered        to the 0 order.    -   Beam Shaping 2, after the beam has passed through the AOM        additional beam shaping is required to fit the system. For        example the beam diameter has to be enlarged to fit the used        objective (0710), to allow the use of the numerical aperture of        the objective.    -   A Diagnostics (0705) system is used to measure the wavelength,        energy per pulse and the pulse width of the laser beam. This        feature in included to allow the safe and repeatable use of the        system. If one of the variables is not performing as planned the        system will shut down and    -   Laser Microscope Coupling (Mirror Arm) (0706) is used to        redirect the laser beam into the laser microscope head.        Depending on the system setup and laser orientation it can        contain between one and multiple mirrors to redirect the laser        beam to the needed position.    -   The Camera System (0707) is used to position the sample towards        the microscope objective. It also is used to find the correct Z        location, depending on the materials curvature. Additionally the        camera can be used for tracking purposes.    -   The Scanner (0708) is used to distribute the laser spot on the        XY plane. Different scanners can be used for this purpose.        Depending on the scanner type the untreated area would still be        covered but with no laser energy per pulse or only the treated        areas would be covered. For this purpose the software        controlling will also control the AOM because the scanner        software will position the spot and the AOM will contribute the        energy per pulse for that spot.    -   The Z Module (0709) can be used to allow an extra focusing        element in the system, this for example can be used for tracking        purposes for a plane in a different Z location than the shaping        plane. It also could be used to change the Z location during the        shaping process.    -   The Objective (0710) focuses the beam on the sample and        determines the spot size. With a larger spot size a larger        energy per pulse is required it therefore has to be fitted to        the laser source and the required precision of the process.        Additionally it provides the field size of the shaping process,        if the field size of the objective is smaller than the required        lens, this requires additional hardware for the lens shaping.    -   The Objective and Sample Interface (0711) is depending on the        application. For the lens manufacturing the space between the        sample and the objective is filled with water to reduce        scattering and allow an additional cooling element. For other        applications different contact method with other mediums like        eye gel could be used.    -   The Sample (0712) can surprise of different optical mediums and        could for example be a hydrophobic polymer which is placed in        front of the objective. Depending on the application that sample        will be directly after the Objective and Sample interface or        deeper inside an additional medium combination like an eyeball.    -   The Positioning System (0713) can be used to position the blocks        comprising of the objective field sizes towards each other to        allow the shaping of a larger structure. It can also be used to        move the sample in the Z direction.

One skilled in the art will recognize that a particular inventionembodiment may include any combination of the above components and mayin some circumstances omit one or more of the above components in theoverall system implementation.

Comparison of Prior Art/Present Invention (0800)

A comparison of the prior art and present invention methodologies forachieving optical convergence within a lens structure is generallyillustrated in FIG. 8 (0800). The prior art as generally depicted inFIG. 8 (0800, 0810) makes use of convex lens formation methodologies togenerate optical convergence as illustrated in this example. It isessential to note that the prior art makes no change in hydrophilicityof the lens material but simply changes the refractive index of thematerial. By contrast, the present invention using changes in PLMhydrophilicity as generally illustrated in FIG. 8 (0800, 0820) togenerate optical convergence. While both techniques may make use ofmultiple lens structures, the present invention relies on negativediopter material modification (0821) to create these lens formations(all increases in hydrophilicity reduce the refractive index of thematerial while all the prior art makes changes in the material thatcreate positive diopter material modification (0811).

Exemplary Application Context Overview (0900)

As generally depicted in FIG. 9 (0900), the present invention uses afemtosecond pulse laser (0911) to enable a hydrophilicity change(alteration) (0912) inside a PLM (0913). As generally depicted in FIG. 9(0900), a three dimensional layer (0922) of hydrophilicity change(alteration) can be shaped in a PLM (0921) using a XYZ stage system. Thedepth of the layer is predetermined in the software. The layer could bepositioned at the surface (0923) or intermediate layers (0924, 0925).

The present invention also anticipates a system configured to formoptical lenses from a PLM, a method by which lenses may be formed usingPLM, and the lenses formed by the method using the PLM. Any of theseinvention embodiments may be applied to situations in which a lensimplanted in a human (or other biologic eye) may be modified and/orcorrected in situ without the need for removal of the lens from thepatient.

The present invention can also be used to create hydrophilic channelswithin a PLM. Such areas can be used to facilitate the passage of otherchemical substances into our out of such materials.

Exemplary Lens Formation Structures (1000)-(1300)

While the present invention may in many contexts be applied to theformation of a wide variety of lens structures, several forms arepreferred. These include but are not limited to convex (1001) andbiconvex (1002) structures as depicted in the profiles of FIG. 10(1000); concave (1101) and biconcave (1102) structures as depicted inthe profiles of FIG. 11 (1100); and phase wrapping convex (1201) andphase wrapping concave (1202) structures as depicted in the profiles ofFIG. 12 (1200). One skilled in the art will recognize that these lensstructures are only exemplary of a wide variety of lenses that may beformed using the teachings of the present invention. Additionally, thelayering of PLM modified structures as depicted in FIG. (0900, 0921) maypermit the layering of a plurality of lens structures within a singlePLM.

Phase Wrapping Lens (1200.1300)

The present invention may be used to form phase wrapping lens asgenerally depicted in the phase wrapping convex (1201) and phasewrapping concave (1202) structures depicted in FIG. 12 (1200) and theassociated exemplary refractive indexes depicted in FIG. 13 (1300).Phase wrapping lenses use the same theoretical idea as the Fresnel lens(1204). The difference in quality can be summarized in three differentfactors:

-   -   the original lens curvature is preserved for the Phase Wrapping        lens;    -   the laser shaping technique allows the preservation of the 90        degree angle at each zone for the Phase Wrapping lens; and    -   the micrometer precision to which the Phase Wrapping lens may be        shaped.        In contrast, the limitations for the Fresnel lens (1205) are        generally derived from the manufacturing process in which it is        created. The main manufacturing difference for a Phase Wrapping        Lens and a Fresnel lens are shown in image 1206.

Refractive Index Gradient Lens (1300)

The present invention may be used to form a refractive index gradientlens as generally depicted in FIG. 13 (1300). The information of thelens curvature is in this concept is stored in a single layer. Thegrayscale values are used to represent the energy per pulse. Therefore256 variations of the power between 0% and 100% are possible and allowthe precise shaping of a single layered lens. The top view of arefractive index lens (1301) shows the different zones of an originalconvex phase wrapping lens. Each original discussed lens type datainformation can be compressed to one single layer. The side view of therefractive index gradient lens (1302) shows the energy distribution ateach spot for one horizontal slice through the center of the lens.

The modulation of the pulse energy can be accomplished using the AOM oran automatic variable attenuator.

PLM Method (1400)

The present invention method anticipates a wide variety of variations inthe basic theme of implementation, but can be generalized as depicted inFIG. 14 (1400) as a lens formation method using hydrophilicityalteration comprising:

-   -   (1) generating a pulsed laser radiation output from a laser        source (1401);    -   (2) distributing the pulsed laser radiation output across an        input area of a microscope objective (1402);    -   (3) accepting the distributed pulsed radiation into a numerical        aperture within the microscope objective to produce a focused        laser radiation output (1403); and    -   (4) transmitting the focused laser radiation output into a PLM        to modify the hydrophilicity within the PLM (1404).        This general method may be modified heavily depending on a        number of factors, with rearrangement and/or addition/deletion        of steps anticipated by the scope of the present invention.        Integration of this and other preferred exemplary embodiment        methods in conjunction with a variety of preferred exemplary        embodiment systems described herein is anticipated by the        overall scope of the present invention. This and other methods        described herein are optimally executed under control of a        computer system reading instructions from a computer readable        media as described elsewhere herein.

As generally depicted in FIG. 9 (0900, 0912), this region of hydrophilicalteration may form arbitrary optical lens structures as generallydepicted in FIG. 10 (1000)-FIG. 13 (1300) having multiple optical innerlayers of hydrophilic alteration as generally depicted in FIG. 9 (0900,0921).

Lens Shaping/Formation Method (1500)

The present invention also teaches a lens shaping/formation methodwherein a lens of arbitrary complexity may be formed within PLM. Thelens shaping consists of different parts. First the lens diopter andcurvature have to be calculated depending on the selected material. Thelaser wavelength afterward is also adjusted towards this material. TheAOM functions as the shutter and also as a variable power attenuator inthe setup, allowing (in combination with the scanner) the lens structureto be precisely shaped inside the polymer. The AOM is controlled by theinput images of the calculated lens information, providing the laserpower information for each area (micrometer) of irradiated area. Thescanner afterward distributes the power to the correct location and themicroscope objective focuses the pulsed laser beam to the desired focusspot inside the polymer. The PLM sample is kept in a sample holder afterthe microscope objective and is optionally positioned on a stage system(mechanized X/Y/Z positioning system) to allow the shaping of a largerlens structure. The stage system could also be replaced with a mirroredlaser arm which ends with the microscope objective. The mirrored arm inthis case would not only replace the stage system but the whole cameraand scanner board.

The present invention method may incorporate an embodiment of this lensshaping/formation method as depicted in FIG. 15 (1500) comprising:

-   -   (1) executing lens calculations to determine the form and        structure of lens to create (1501);    -   (2) selecting the laser wavelength suitable for the desired        hydrophilicity change in the PLM (1502);    -   (3) shuttering and/or power regulating a laser using an AOM or        equivalent modulator to generate laser pulses (1503);    -   (4) scanning the laser pulses across a microscope objective        (1504);    -   (5) forming a laser spot size and precisely positioning the        focused laser within a PLM using a microscope objective (1505);    -   (6) retaining/holding the PLM for hydrophilicity alteration by        the laser pulse stream (1506); and    -   (7) optionally positioning the target PLM sample using X/Y/Z        positioning system (1507).        This general method may be modified heavily depending on a        number of factors, with rearrangement and/or addition/deletion        of steps anticipated by the scope of the present invention.        Integration of this and other preferred exemplary embodiment        methods in conjunction with a variety of preferred exemplary        embodiment systems described herein is anticipated by the        overall scope of the present invention.

This method may be applied to one or more layers within the PLM toachieve formed lens structures of arbitrary complexity. The lenscalculations associated with this procedure as identified in step (1)are detailed in FIG. 16 (1600) and described below.

Lens Calculation Method (1600)

The present invention also teaches a lens calculation method whereinlens parameters are used to determine the internal PLM lens structurethat is customized for a particular patient and their unique opticalrequirements. This method generally involves the following steps:

-   -   Calculating the curvature of the lens to be formed;    -   Determining the required lens depth;    -   Calculating the number of zones which must be processed via the        laser;    -   Determining the zone radius for each zone to be processed;    -   Create phase wrapping lens data files for the laser; and    -   Loading the data files into the RIS mapping system.        These steps will now be discussed in more detail.

Before the lens parameters for a custom intraocular lens (IOL) can becalculated the patient needs to be examined, the different existingaberrations can be measured and the needed diopter (Dpt) changes can beevaluated. The material (n) for the shaping process has to be known tocalculate the lens curvature (C).

$\begin{matrix}{C = \frac{Dpt}{( {n^{\prime} - n} )}} & (1)\end{matrix}$

Where n is the refractive index of the original IOL material and n′ isthe refractive index after the RIS shaping, and therefore the refractiveindex of the new lens.

$\begin{matrix}{C = \frac{1}{r}} & (2)\end{matrix}$

The curvature is related to lens radius (r) and the radius can becalculated with the lens diameter 2w_(Lens) and the lens depth h_(Lens).

$\begin{matrix}{r = \frac{h_{Lens}^{2} + w_{Lens}^{2}}{2h_{Lens}}} & (3)\end{matrix}$

Afterward the Phase Wrapping Lens Information is calculated for thegiven information and the output images are created. All requiredinformation for the Phase Wrapping Lens already exists in theinformation of the original lens and its curvature. The Phase Wrappingdepth of the lens is determined by the refractive index change amount.Afterward the radius of each zone and for the curvature information ofeach zone can be easily calculated. Depending on the shaping techniquethe lens diopter can be larger than the objective field size, in thiscase a stage system (as described above) is used to align the differentareas for the lens shaping. To allow this technique the input images arechopped into their images sizes to represent the block system.

The lens calculation method described above and generally depicted inFIG. 15 (1500, 1501) may be embodied in many forms, but severalpreferred embodiments of the present invention method may implement thismethod as depicted in FIG. 16 (1600) using the following steps:

-   -   (1) measuring or determining required lens properties for        desired optical performance (1601);    -   (2) selecting a lens material appropriate for lens fabrication        (1602);    -   (3) calculating the desired lens curvature (1603);    -   (4) calculating phase wrapping lens information necessary to        form the lens (1604);    -   (5) creating output images that correspond to the desired phase        wrapping lens characteristics (1605);    -   (6) determining if the lens treatment area is larger than the        objective field size, and if not, proceeding to step (8) (1606);    -   (7) chopping the output images into segments that fit within the        field size (1607);    -   (8) determining if the patient (or lens formation) requires        additional lens properties, and if so, proceeding to step (1)        (1608); and    -   (9) terminating the lens calculation method (1609).        This general method may be modified heavily depending on a        number of factors, with rearrangement and/or addition/deletion        of steps anticipated by the scope of the present invention.        Integration of this and other preferred exemplary embodiment        methods in conjunction with a variety of preferred exemplary        embodiment systems described herein is anticipated by the        overall scope of the present invention.

This method may be applied to the formation of lenses that areretained/held by a staging apparatus, or in some circumstances the lensshaping/formation process may be performed in situ within the eye of apatient. In this situation, the lens PLM may be surgically inserted intothe patient while the PLM is in a generally unmodified (or previouslymodified) state and then “dialed-in” to provide optimal vision for thepatient.

Application #1—Optical Lens (1700)-(1800)

The following experimental application example discusses an internalhydrophilicity change for a polymeric acrylic polymer suitable formaking optical lenses.

Step 1—Preparation of Testing Optical Material

A small sheet of crosslinked polymeric copolymers may be constructed byfree radical polymerization of

-   -   (1) 140 grams of mixture of butylacrylate, ethylmethacrylate,        N-benzyl-N-isopropylacrylamide, and ethylene glycol        dimethacrylate;    -   (2) 11.4 grams of        2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl methacrylate;        and    -   (3) a yellow dye less than 0.5%.        under a curing cycle starting at 65° C. up to 140° C. for a        total time of approximately 14 hours in a glass mold sealed with        silicone tube. Slightly yellow transparent sheet, about 2 mm        thick, obtained this way can be cut into round buttons which can        be further lathe machined into intraocular lenses.        Alternatively, small trips can also be cut out from the sheet or        from the buttons for laser treatment. The refractive index of        the yellow sheet or button prepared this way is approximately        1.499.

Step 2—Pre-Soaking

A small strip (1.91 mm×1.33 mm×14.35 mm) of an optically transparentlens material prepared above weighs 38.2 mg. This strip of lens materialis soaked in water until no more weight increase, an indication forreaching saturation at room temperature. The saturated strip, afterwater droplets on its surface are wiped with dry paper tissues, weighs38.3 mg, indicating water absorption is approximately 0.3%.

Step 3—Laser Treatments

The water saturated strip was then exposed to laser pulses from afemtosecond laser source (pulse width: 200 fs, repetition rate: 50 MHz,energy per pulse: 5.4 nJ, wavelength: 780 nm). Only a predeterminedregion (2 mm×2 mm×165 μm, 165 μm is the thickness of the treated region)as generally illustrated in FIG. 17 (1700) of the strip was treated.After the treatment the strip was allowed to be saturated with water andthen weighed again. The strip was 38.9 mg with an increase of 0.2 mgwhich represents approximately 30% water absorption by the treatedregion (0.2 mg 2×1.9×0.165=0.318=32%). After the first region wastreated, a second region of same dimension was treated, approximatelyanother 0.2 mg increase was observed. This way, a total of 3 regionswere treated, final strip weights 38.9 mg. The weight gains after eachlaser treatment are summarized in the graph depicted in FIG. 18 (1800).

Application #2—Diffraction Gratings (1900)-(2400)

The following experimental application example discusses the use of thepresent invention as applied to Diffraction gratings efficiencydependency on water absorption.

Step 1

A diffraction grating was shaped inside the acrylic polymeric materialas generally depicted in FIG. 19 (1900). The grid size is 3 mm with an Xspacing of 18 um in this example.

Step 2

The sample is then water saturated.

Step 3

The efficiency of the refractive index grating was measured (2103) usingthe setup depicted in FIG. 20 (2000) for different scan speeds. A red(640 nm) laser was placed in front of the sample. The sample is mountedon a set of XY stages to allow positioning of the grating in regards ofthe laser. At some distance a screen (2101-2103) was positioned and thepower of the different orders of the gratings (as depicted in FIG. 21(2100)) is recorded for different times as depicted in FIG. 22 (2200).The power in the 1^(st) to the 10^(th) order decreases with the waterdesaturation as illustrated in FIG. 22 (2200), while the energy is goinginto the zero (0) order as generally depicted in FIG. 23 (2300).

This can be compared with the water de-absorption curve of the acrylicpolymeric material as depicted in FIG. 24 (2400) which shows thematerial weight loss due to water de-absorption. The graph in FIG. 24(2400) shows the averaged sample weight measurement in percentage for 10samples. The important information is shown in the first five (5) hours.The main change is occurring within the first five hours comparing thegraphs in FIG. 23 (2300) and FIG. 24 (2400). The diffraction gratingstarts decrease slower because the grating is shaped inside the materialand the water de-absorption takes some time before it will be noticed inthe measurement. After the main water amount is de-absorbed thediffraction grating gets very weak.

Application #3—Phase Wrapping Convex Lens (2500)-(2900)

The following experimental application example discusses a negativerefractive index change due to hydrophilicity change.

Step 1

A lens shaping of a phase wrapping convex lens is generated as depictedin FIG. 25 (2500). The phase wrapping concave lens shows the negativerefractive index change which is induced by the hydrophilicity changeinside the material. The NIMO diopter reading for this structure isdepicted in FIG. 26 (2600).

The convex phase wrapping lens shows a negative diopter reading and theconcave phase wrapping lens as generally depicted in FIG. 27 (2700)shows a positive diopter reading. The NIMO diopter reading for thisstructure is depicted in FIG. 28 (2800).

The image depicted in FIG. 29 (2900) illustrates an exemplary 3 mmconvex phase wrapping lens top view as constructed.

Application #4—Water Saturation (3000)-(3100)

The following experimental application example discusses a full diopterreading only after water saturation of the material.

Step 1

A concave lens with a positive diopter reading was shaped.

Step 2

The lens diopter is measured after shaping.

Step 3

The lens is not stored in water but in air for 18 days and afterwardplaced in water.

Step 4

The diopter reading of the lens after placed in water is measured.

The diopter reading of the lens directly after shaping is minimal. Thematerial still has to be water saturated before the final diopterreading is possible. During the shaping process it already can absorbsome water, therefore some diopter reading will be possible aftershaping but the full diopter reading will always only be possible afterthe material is fully water saturated.

After the lens is placed in water the lens diopter is fully recoveredafter 24 hours. FIG. 30 (3000) depicts the diopter reading of a 5diopter 2 mm lens. The first diopter measurement directly after shapingwas only 1.5D.

For comparison graph in FIG. 31 (3100) depicts the water saturationcurve for the polymeric material and its relationship to time.

Application #5—Pre-Soaking

The following experimental application example discusses the diopterreading of a pre-soaked sample.

The saturation period can be shortened if the sample was pre-soaked inwater before the lens shaping. Directly after shaping the lens shows alarger diopter reading and will recover to the full diopter value muchquicker, compared to a non-pre-soaked sample. The pre-water soaking willonly shorten the time period of the sample to fully saturate. It willnot change the final diopter reading of the lens.

Application #6—Temperature Dependency (3100)

The following experimental application example discusses the temperaturedependency of lens diopter.

The water absorption of the material is dependent on the surroundingtemperature. An incubator can be used to change the sample temperature.After allowing the sample sufficient time to adapt to the temperaturechange the lens diopter was measured and differences of up to ±1D fordifferent temperature settings were observed.

The water absorption is temperature dependent, therefore the diopterreading of the lens is also temperature dependent. This can be seen fromthe graph in FIG. 31 (3100), wherein more water is absorbed for 35degree Celsius than for 22 degree Celsius.

Application #7—Diopter Memory (3200)

The following experimental application example discusses the temperaturedependency of lens diopter.

The diopter of the treated area is fixed. The sample can be kept in airstorage, never allowing it to develop the full lens diopter, but whenplaced in water the full diopter of the lens will recover to the full,theoretically calculated diopter after saturation.

Diopter reading of sample increases when hydrated after sample wasdehydrated, the lens starts with approximately 0D and increases thediopter reading to its full −6D within 27 hours as depicted in FIG. 32(3200), which is in accordance with the image in FIG. 31 (3100).

In-Vivo Lens Shaping Method (3300)-(4000)

The present invention anticipates that lenses may be formed/shaped usingthe systems/methods described herein in-vivo as generally illustrated inFIG. 33 (3300), comprising the following steps:

-   -   (1) Preparation (3391);    -   (2) Lens Data Creation (3392);    -   (3) Patient Interfacing (3393);    -   (4) Start Initialization (3394);    -   (5) Diagnostics (3395);    -   (6) Lens Shaping (3396); and    -   (7) Verification (3397).        As generally illustrated in FIG. 34 (3400)-FIG. 40 (4000), these        generalized steps may be further defined in terms of more        detailed steps as follows:    -   (1) Patient existing lens material determination (3401) wherein        this information is used to determine the laser properties and        to calculate the refractive index material change induced by the        refractive index shaping.    -   (2) Patient aberration measurement (3402) wherein the different        patient specific aberrations are determined.    -   (3) Patient selects which aberrations need treatment (3403)        wherein the selection could be but is not limited to common        vision defects like myopia, hyperopia and astigmatism.    -   (4) Doctor selects needed lens information and lens material        (3504) wherein the selection is depending on the consultation        with the patients' needs and the available options.    -   (5) Determining if needed lens information exists, and if the        information already exists, proceeds to step (11) (3505). This        section is completely software based and not accessible by the        doctor or the patient. This step is integrated for the case that        a patient has a unique diopter value which is not preloaded to        the system.    -   (6) Calculating lens curvature (3506) wherein the curvature is        depending on the required lens diopter and the refractive index        change induced by the refractive index shaping and the        surrounding refractive index change of the material.    -   (7) Determining phase weighting height (3507) wherein the height        is depending on the induced refractive index change difference        and therefore also the surrounding material.    -   (8) Phase wrapping lens creation (3508) wherein the information        of the Phase Wrapping Lens is given by the Phase Wrapping Lens        height and the original lens curvature information. For each        layer the radii for each zone can be determined using this        information.    -   (9) Data output file creation (3509), the information for each        layer, and possible each block of each layer will be created        using the information from the phase wrapping lens (3508).    -   (10) Data loading to system (3510) wherein the data files (3509)        might need additional time to be loaded into the existing        software to be analysed and depending on the material the line        pitch can be used to fill the 3 dimensional structure.    -   (11) Patient is positioned towards the system (3611) wherein        this positioning is the initial step for the patient interface        positioning. The patients head is aligned towards the refractive        index shaping work station.    -   (12) Doctor positions the objective towards the patient's iris        (3612) The doctor can use the camera module to get a good idea        of the position of the objective towards the iris. This is an        important step because this position will also be used for the        tracking.    -   (13) Doctor enters patient ID into the system (3713) wherein the        software will display the patient's information and the        pre-selected shaping options.    -   (14) Doctor verifies information and selects START (3714)        wherein the doctor verifies in the first step the patient's        identity and afterward the selected treatment options.    -   (15) System checks if laser wavelength is correct (3815) wherein        the laser wavelength is selected in regards of the original lens        material. The diagnostic tool for of the system afterward checks        that the displayed wavelength and the real time value of the        system are a match;    -   (16) System checks if energy is stable (3816) wherein the laser        energy is measured. The diagnostic tool for of the system        afterward checks that the theoretical calculated energy and the        real time value of the system are matching.    -   (17) System check if pulse width is stable (3817) wherein the        diagnostic tool is used to internal check that the pulse width        of the system has not changed.    -   (18) Z module is used for the Z positioning of the focus spot        (3918) wherein the Z module is used to vary the distance between        the lens shaping focus spot and the iris tracking focus spot.        The IOL inside the patient's eye can settle differently and also        the patients cornea thickness and anterior chamber thickness is        variable, therefore the Z module is used to find the correct        location for the refractive index shaping lens.    -   (19) Scanner is used for the focus spot position (3919) wherein        the scanner positions the focus spot to the correct shaping        location.    -   (20) AOM is used for the energy distribution (3920) wherein the        AOM provides the correct energy per pulse for the scanner        location. and    -   (21) New lens diopter is verified (4021) wherein the patient's        new diopter reading is measured and verified.        This general method may be modified heavily depending on a        number of factors, with rearrangement and/or addition/deletion        of steps anticipated by the scope of the present invention.        Integration of this and other preferred exemplary embodiment        methods in conjunction with a variety of preferred exemplary        embodiment systems described herein is anticipated by the        overall scope of the present invention.

Manufacturing Custom Lens Shaping Method (4100)-(4800)

The present invention anticipates that lenses may be formed/shaped usingthe systems/methods described herein with a custom manufacturing processas generally illustrated in FIG. 41 (4100), comprising the followingsteps:

-   -   (1) Preparation (4191);    -   (2) Lens Data Creation (4192);    -   (3) Positioning (4193);    -   (4) Start Initialization (4194);    -   (5) Diagnostics (4195);    -   (6) Lens Shaping (4196); and    -   (7) Verification/shipping (4197).        As generally illustrated in FIG. 42 (4200)-FIG. 48 (4800), these        generalized steps may be further defined in terms of more        detailed steps as follows:    -   (1) Patient selects lens material determination (4201) wherein        the patient has the option to choose the material used from the        list of available options.    -   (2) Patient aberration measurement (4202) wherein the patient's        aberrations are measured.    -   (3) Patient selects which aberrations need treatment (4203)        wherein depending on patient's requirement or availability the        treatment option is chosen.    -   (4) Doctor selects needed lens information and lens material        (4304) wherein the patient's choice for the material and        required changes is revised and if needed a new selection is        required and will be discussed with the patient.    -   (5) Determining if needed lens information exists, and if        existing, proceeding to step (11) (4305) wherein the software        checks internally if the required aberration code already exists        or if new code has to be created for the patient.    -   (6) Calculating lens curvature (4306) wherein the curvature is        depending on the required lens diopter and the refractive index        change induced by the refractive index shaping and the        surrounding refractive index change of the material.    -   (7) Determining phase wrapping height (4307) wherein the height        is depending on the induced refractive index change difference        and therefore also the surrounding material.    -   (8) Phase wrapping lens creation (4308) wherein the information        of the Phase Wrapping Lens is given by the Phase Wrapping Lens        height and the original lens curvature information. For each        layer the radii for each zone can be determined using this        information.    -   (9) Data output file creation (4309) wherein the information for        each layer, and possible each block of each layer will be        created using the information from the phase wrapping lens        (3508)    -   (10) Data loading to system (4310) wherein the lens/blank is        positioned inside the system.    -   (11) Lens/blank is positioned in the manufacturing system (4411)        wherein the system selects the starting position for the lens        shaping.    -   (12) Technician enters the Customer ID (4512) wherein the        software will display the patient's information and the        pre-selected shaping options.    -   (13) Technician verifies information and selects START (4513)        wherein the technician verifies in the first step the patient's        identity and afterward the selected treatment options.    -   (14) System checks if laser wavelength is correct (4614) wherein        the laser wavelength is selected in regards of the original lens        material. The diagnostic tool for of the system afterward checks        that the displayed wavelength and the real time value of the        system are a match.    -   (15) System checks if energy is stable (4615) the laser energy        is measured. The diagnostic tool of the system afterward checks        that the theoretical calculated energy and the real time value        of the system are matching;    -   (16) System check if pulse width is stable (4616) wherein the        diagnostic tool is used to internal check that the pulse width        of the system has not changed.    -   (17) Z module is used for the Z positioning of the focus spot        (4717) wherein the Z module is used to vary the distance between        the lens shaping focus spot and the iris tracking focus spot.        The IOL inside the patient's eye can settle differently and also        the patients cornea thickness and anterior chamber thickness is        variable, therefore the Z module is used to find the correct        location for the refractive index shaping lens.    -   (18) Scanner is used for the focus spot position (4718) wherein        the scanner positions the focus spot to the correct shaping        location.    -   (19) AOM is used for the energy distribution (4719) wherein the        AOM provides the correct energy per pulse for the scanner        location.    -   (20) A X and Y stage system is used to support a larger        treatment area (4720) wherein the X and Y stages are used to        shape a lens which is larger than the shaping area of the given        objective. and    -   (21) A Z-stage is used to allow the movement between layers        (4721) wherein the Z stage can additional be used for the Z        movement of the different layers of the lens.    -   (22) New lens diopter is verified (4822) wherein the IOL's new        diopter reading is measured and verified.    -   (23) Lens is packaged and shipped to doctor (4823) wherein the        product is packed and shipped.        This general method may be modified heavily depending on a        number of factors, with rearrangement and/or addition/deletion        of steps anticipated by the scope of the present invention.        Integration of this and other preferred exemplary embodiment        methods in conjunction with a variety of preferred exemplary        embodiment systems described herein is anticipated by the        overall scope of the present invention.

PM System Summary

The present invention system may be broadly generalized as a system forchanging the hydrophilicity of an internal region of a polymericmaterial, said system comprising:

-   -   (a) laser source;    -   (b) laser scanner; and    -   (c) microscope objective;    -   wherein    -   the laser source is configured to emit a pulsed laser radiation        output;    -   the laser scanner is configured to distribute the pulsed laser        radiation output across an input area of the microscope        objective;    -   the microscope objective further comprises a numerical aperture        configured to accept the distributed pulsed laser radiation and        produce a focused laser radiation output; and    -   the focused laser radiation output is transmitted by the        microscope objective to an internal region of a polymeric        material (PM);    -   the focused laser radiation output changes the hydrophilicity        within the internal region of the PM.

This general system summary may be augmented by the various elementsdescribed herein to produce a wide variety of invention embodimentsconsistent with this overall design description.

PLM System Summary

The present invention system anticipates a wide variety of variations inthe basic theme of construction, but can be generalized as a lensformation system comprising:

-   -   (a) laser source;    -   (b) laser scanner; and    -   (c) microscope objective;    -   wherein    -   the laser source is configured to emit a pulsed laser radiation        output;    -   the laser scanner is configured to distribute the pulsed laser        radiation output across an input area of the microscope        objective;    -   the microscope objective further comprises a numerical aperture        configured to accept the distributed pulsed laser radiation and        produce a focused laser radiation output; and    -   the focused laser radiation output is transmitted by the        microscope objective to a PLM;    -   the focused laser radiation interacts with the polymers within        the PLM and results in a change the hydrophilicity within the        PLM.

This general system summary may be augmented by the various elementsdescribed herein to produce a wide variety of invention embodimentsconsistent with this overall design description.

PM Method Summary

The present invention method may be broadly generalized as a method forchanging the hydrophilicity of an internal region of a polymericmaterial, the system comprising:

-   -   (1) generating a pulsed laser radiation output from a laser        source;    -   (2) distributing the pulsed laser radiation output across an        input area of a microscope objective;    -   (3) accepting the distributed pulsed radiation into a numerical        aperture within the microscope objective to produce a focused        laser radiation output; and    -   (4) transmitting the focused laser radiation output to an        internal region of polymeric material (“PM”) to modify the        hydrophilicity within the internal region of the PM.        This general method may be modified heavily depending on a        number of factors, with rearrangement and/or addition/deletion        of steps anticipated by the scope of the present invention.        Integration of this and other preferred exemplary embodiment        methods in conjunction with a variety of preferred exemplary        embodiment systems described herein is anticipated by the        overall scope of the present invention.

PLM Method Summary

The present invention method anticipates a wide variety of variations inthe basic theme of implementation, but can be generalized as a lensformation method comprising:

-   -   (1) generating a pulsed laser radiation output from a laser        source;    -   (2) distributing the pulsed laser radiation output across an        input area of a microscope objective;    -   (3) accepting the distributed pulsed radiation into a numerical        aperture within the microscope objective to produce a focused        laser radiation output; and    -   (4) transmitting the focused laser radiation output into a PLM        to modify the hydrophilicity within the PLM.        This general method may be modified heavily depending on a        number of factors, with rearrangement and/or addition/deletion        of steps anticipated by the scope of the present invention.        Integration of this and other preferred exemplary embodiment        methods in conjunction with a variety of preferred exemplary        embodiment systems described herein is anticipated by the        overall scope of the present invention.

PM Product-By-Process

The present invention method may be applied to the modification of thehydrophilicity of an arbitrary polymeric material, wherein theproduct-by-process is a modified polymeric material (PM) comprisingsynthetic polymeric materials further comprising a plurality of modifiedhydrophilicity zones formed within the polymeric material (PM), theplurality of modified hydrophilicity zones created using a methodcomprising:

-   -   (1) generating a pulsed laser radiation output from a laser        source;    -   (2) distributing the pulsed laser radiation output across an        input area of a microscope objective;    -   (3) accepting the distributed pulsed radiation into a numerical        aperture within the microscope objective to produce a focused        laser radiation output; and    -   (4) transmitting the focused laser radiation output to an        internal region of polymeric material (PM) to modify the        hydrophilicity within the internal region of the PM.        This general product-by-process method may be modified heavily        depending on a number of factors, with rearrangement and/or        addition/deletion of steps anticipated by the scope of the        present invention. Integration of this and other preferred        exemplary embodiment methods in conjunction with a variety of        preferred exemplary embodiment systems described herein is        anticipated by the overall scope of the present invention.

PLM Product-By-Process

The present invention method may be applied to the formation of anoptical lens, wherein the product-by-process is an optical lenscomprising synthetic polymeric materials further comprising a pluralityof optical zones formed within a PLM, the plurality of optical zonescreated using a lens formation method comprising:

-   -   (1) generating a pulsed laser radiation output from a laser        source;    -   (2) distributing the pulsed laser radiation output across an        input area of a microscope objective;    -   (3) accepting the distributed pulsed radiation into a numerical        aperture within the microscope objective to produce a focused        laser radiation output; and    -   (4) transmitting the focused laser radiation output into a PLM        to modify the hydrophilicity within the PLM.        This general product-by-process method may be modified heavily        depending on a number of factors, with rearrangement and/or        addition/deletion of steps anticipated by the scope of the        present invention. Integration of this and other preferred        exemplary embodiment methods in conjunction with a variety of        preferred exemplary embodiment systems described herein is        anticipated by the overall scope of the present invention.

System/Method/Product-by-Process Variations

The present invention anticipates a wide variety of variations in thebasic theme of construction. The examples presented previously do notrepresent the entire scope of possible usages. They are meant to cite afew of the almost limitless possibilities.

This basic system, method, and product-by-process may be augmented witha variety of ancillary embodiments, including but not limited to:

-   -   An embodiment wherein the distribution of the focused laser        radiation output is configured to be larger than the field size        of the microscope objective by use of an X-Y stage configured to        position the microscope objective.    -   An embodiment wherein the laser source further comprises a        femtosecond laser source emitting laser pulses with a megahertz        repetition rate.    -   An embodiment wherein the pulsed laser radiation output has        energy in a range of 0.17 to 500 nanojoules.    -   An embodiment wherein the pulsed laser radiation output has a        repetition rate in the range of 1 MHz to 100 MHz.    -   An embodiment wherein the pulsed laser radiation output has a        pulse width in the range of 10 fs to 350 fs.    -   An embodiment wherein the focused laser radiation output has a        spot size in the X-Y directions in the range of 0.5 to 10        micrometers.    -   An embodiment wherein the focused laser radiation output has a        spot size in the Z direction in the range of 0.01 to 200        micrometers.    -   An embodiment wherein the PLM is shaped in the form of a lens.    -   An embodiment wherein the PLM is water saturated.    -   An embodiment wherein the PLM comprises an intraocular lens        contained within an ophthalmic lens material.    -   An embodiment wherein the PLM comprises an intraocular lens        contained within an ophthalmic lens material, the ophthalmic        lens material located within the eye of a patient.    -   An embodiment wherein the laser scanner is configured to        distribute the focused laser radiation output in a        two-dimensional pattern within the PLM.    -   An embodiment wherein the PLM comprises an intraocular lens        contained within an ophthalmic lens material, the ophthalmic        lens material located within the eye of a patient.    -   An embodiment wherein the laser scanner is configured to        distribute the focused laser radiation output in a        three-dimensional pattern within the PLM.    -   An embodiment wherein the laser scanner is configured to        distribute the focused laser radiation output in a        three-dimensional pattern within the PLM, the pattern forming a        convex lens within the PLM.    -   An embodiment wherein the laser scanner is configured to        distribute the focused laser radiation output in a        three-dimensional pattern within the PLM, the pattern forming a        biconvex lens within the PLM.    -   An embodiment wherein the laser scanner is configured to        distribute the focused laser radiation output in a        three-dimensional pattern within the PLM, the pattern forming a        concave lens within the PLM.    -   An embodiment wherein the laser scanner is configured to        distribute the focused laser radiation output in a        three-dimensional pattern within the PLM, the pattern forming a        biconcave lens within the PLM.    -   An embodiment wherein the laser scanner is configured to        distribute the focused laser radiation output in a        three-dimensional pattern within the PLM; the focused laser        radiation creating a hydrophilicity change in the volume        associated with the three-dimensional pattern; and the        hydrophilicity change resulting in a corresponding change in        refractive index of the volume associated with the        three-dimensional pattern.    -   An embodiment wherein the refractive index change is negative        for the PLM having an initial refractive index greater than 1.3.    -   An embodiment wherein the refractive index change is greater        than 0.005.    -   An embodiment wherein the three-dimensional pattern comprises a        plurality of layers within the PLM.    -   An embodiment wherein the PLM comprises a crosslinked polymeric        copolymer.    -   An embodiment wherein the PLM comprises a crosslinked polymeric        acrylic polymer.    -   An embodiment wherein the laser source further comprises an        Acousto-Optic Modulator (AOM).    -   An embodiment wherein the laser source further comprises a        greyscale Acousto-Optic Modulator (AOM).    -   An embodiment wherein the PLM has been presoaked in a liquid        solution comprising water.    -   An embodiment wherein the PLM comprises an ultraviolet (UV)        absorbing material.

One skilled in the art will recognize that other embodiments arepossible based on combinations of elements taught within the aboveinvention description.

Generalized Computer Usable Medium

In various alternate embodiments, the present invention may beimplemented as a computer program product for use with a computerizedcomputing system. Those skilled in the art will readily appreciate thatprograms defining the functions defined by the present invention can bewritten in any appropriate programming language and delivered to acomputer in many forms, including but not limited to: (a) informationpermanently stored on non-writeable storage media (e.g., read-onlymemory devices such as ROMs or CD-ROM disks); (b) information alterablystored on writeable storage media (e.g., floppy disks and hard drives);and/or (c) information conveyed to a computer through communicationmedia, such as a local area network, a telephone network, or a publicnetwork such as the Internet. When carrying computer readableinstructions that implement the present invention methods, such computerreadable media represent alternate embodiments of the present invention.

As generally illustrated herein, the present invention systemembodiments can incorporate a variety of computer readable media thatcomprise computer usable medium having computer readable code meansembodied therein. One skilled in the art will recognize that thesoftware associated with the various processes described herein can beembodied in a wide variety of computer accessible media from which thesoftware is loaded and activated. Pursuant to In re Beauregard, 35USPQ2d 1383 (U.S. Pat. No. 5,710,578), the present invention anticipatesand includes this type of computer readable media within the scope ofthe invention. Pursuant to In re Nuijten, 500 F.3d 1346 (Fed. Cir. 2007)(U.S. patent application Ser. No. 09/211,928), the present inventionscope is limited to computer readable media wherein the media is bothtangible and non-transitory.

CONCLUSION

A system/method allowing the modification of the hydrophilicity of apolymeric material (PM) has been disclosed. The modification inhydrophilicity (i) decreases the PM refractive index, (ii) increases thePM electrical conductivity, and (iii) increases the PM weight. Thesystem/method incorporates a laser radiation source that generatesfocused laser pulses within a three-dimensional portion of the PM toaffect these changes in PM properties. The system/method may be appliedto the formation of customized intraocular lenses comprising material(PLM) wherein the lens created using the system/method is surgicallypositioned within the eye of the patient. The implanted lens refractiveindex may then be optionally altered in situ with laser pulses to changethe optical properties of the implanted lens and thus achieve optimalcorrected patient vision. This system/method permits numerous in situmodifications of an implanted lens as the patient's vision changes withage.

A lens formation system/method that permits dynamic in situ modificationof the hydrophilicity of the PLM has also been disclosed. Thesystem/method incorporates a laser that generates focused pulses withina three-dimensional portion of PLM to modify the hydrophilicity and thusthe refractive index of the PLM and thus create a customized lens ofarbitrary configuration. The system/method may be applied to theformation of customized intraocular lenses wherein an ophthalmic lensmaterial incorporating homogeneous PLM is surgically positioned withinthe eye of a patient. The patient's vision is analyzed with theophthalmic lens installed and the homogeneous PLM is then irradiated insitu with laser pulses to modify the internal refractive characteristicsof the PLM to achieve optimal corrected patient vision. This exemplaryapplication may permit in situ modification of intraocular lenscharacteristics on a dynamic basis as the patient ages.

Although a preferred embodiment of the present invention has beenillustrated in the accompanying drawings and described in the foregoingDetailed Description, it will be understood that the invention is notlimited to the embodiments disclosed, but is capable of numerousrearrangements, modifications, and substitutions without departing fromthe spirit of the invention as set forth and defined by the followingclaims.

What is claimed is:
 1. A modified polymeric material (PM) comprisingsynthetic polymeric materials further comprising a plurality of modifiedhydrophilicity zones formed within said polymeric material (PM), saidplurality of modified hydrophilicity zones created using a methodcomprising: (1) generating a pulsed laser radiation output from a lasersource; (2) distributing said pulsed laser radiation output across aninput area of a microscope objective; (3) accepting said distributedpulsed radiation into a numerical aperture within said microscopeobjective to produce a focused laser radiation output; and (4)transmitting said focused laser radiation output to an internal regionof said PM to modify the hydrophilicity within said internal region ofsaid PM.